The court-ordered FDA release of Pfizer's COVID-19 vaccine BLA submission (~450K pages across 4 sub-collections), mirrored from PHMPT.org. Searchable with AI explain.
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From: Smith, Michael (CBER) Sent: Tuesday, July 6, 2021 6:40 PM To: Harkins Tull, Elisa <[email protected]>; Aghajani Memar, Neda <[email protected]>; Devlin, Carmel M <[email protected]> Cc: Naik, Ramachandra <[email protected]>; Gottschalk, Laura <[email protected]> Subject: STN 125742.0: Clinical IR RE the document titled “c4591001- interim -mth6 -report -body.pdf” Elisa, We have the following comment regarding the…
From: Smith, Michael (CBER) < [email protected] > Sent: Friday, July 2, 2021 11:38 AM To: Harkins Tull, Elisa < [email protected] >; Aghajani Memar, Neda <[email protected] >; Devlin, Carmel M <Ca [email protected] > Cc: Naik, Ramachandra < [email protected] >; Gottschalk, Laura <[email protected] > Subject: RE: [EXTERNAL] R E: STN 125742.0: Clinical IR RE document titled “bnt162- 01-interim3 -report - body” Elisa, I…
RPM Filing Checklist STN 125742/0 *** For Internal CBER Use Only *** Page 1of 18Application Information BLA STN# 125742/0 Proprietary Name: NOTE : If a primary and alternate are proposed, specify both names, identifying which is primary and which is alternateCOMIRNATY Established/Proper Name: COVID-19 mRNA Vaccine Dosage Form/Strength, if applicable:Suspension for injection. After preparation, a sin gle dose is 0.3 mL (30 mc g) Applicant: BioNTech Manufacturin g GmbH License No.: 2229 If…
Pfizer Inc Lake Forest, IL 60045 DO NOT SCALE TEMPLATEPlant Line(s): RM Lines 1A, 3, 14Dwg. No. DB5706085 AND 10mL LABEL HORIZONTAL ABLATION Reference: Control Level AQL'sDocument Owner: J. CottonVersion: V01Original Source:Dwg. No. TDG031200 Version: V03 GLOBAL SUPPLY2.5 x .875NOTES: 1. Commodity number to be black on white background. 2. Bar code: per market requirements. Human readables not required below bar code, except for Canadian market. Quiet zone not required.Font size 6 point OCRB…
21/64” 1/16” 5/16”11/64” 11/64” 2.15625”0.75” 1/64”Z18AV ZZ BLACK PMS182C DIE Cross Tech–90500–Proof 1 Page M01 Fresenius Kabi USA, LLC P.O. 4700010512–Job No. 401817G 11/17/20–bw–InddCC15 Fonts: Helvetica Neue (A) Helvetica (A) Typesmiths Pi Font Interstate OCRB LOT/EXP401817GNDC 63323 186 04 918602 Sodium Chloride Injection, USP 0.9% 2 mL Single Dose Vial FOR DRUG D LUENT USE Preservative Free Rx only Discard unused portion 3 63323-186-04 3Fresenius…
42598F Cross Tech–90501–Proof 1 Page M01 Fresenius Kabi USA, LLC P.O. 4700010512–Job No. 42598F 11/17/20–bw–InddCC15 Fonts: Helvetica Neue (A ) Helvetica (A) Typesmiths Pi Font Interstate OCRBBLACK PMS182C DIE18AB Fresenius Kabi Lake Zurich, IL 60047 (01)20363323186023Sterile, Nonpyrogenic Preservative Free Discard unused portion. Each mL contains: Sodium chloride 9 mg; Water for Injection q.s. HCI and/or NaOH may have been added for pH adjustment. 0.3…
Plant Line(s): RM Line (various)Dwg. No. N/A10mL PLASTIC VIAL Reference: 3C die line CC11545 Document Owner: J. CottonVersion: N/ADRAWING TEMPLATE Original Source:Dwg. No. DWG-50061378 Version: V02NOTES: 1. Commodity number to be 8 point OCRB Medium black on white background.FOR SERIALIZED 5.3437 x 5.3437 x 1.25 2. Length, width, and depth tolerance ±1/32 inch. Pfizer Inc Lake Forest, IL 60045 DO NOT SCALE TEMPLATEControl Level AQL's GLOBAL SUPPLYPALMER TRAY 11-15-173. For Rocky Mount,…
Annotated Stud y Book for Stud y Desi gn: C4591001 Stud y Desi gn Version: 14.0 Sponsor: Pfizer Protocol: C4591001 Sponsor Dru g Name: BLINDED THERAPY C4591001 - COVID19 Generated by Central Designer TM January 14, 2021 12:00PMAnnotated Study Book - C4591001 Page 1 of 131 090177e19733f389\Final\Final On: 04-Jun-2021 01:50 (GMT) FDA-CBER-2021-5683-1007350 Vis its SCR MA IN INFORMED CONSENT DEMOGRAPHY DATE OF VISIT INCLUSION/EXCLUSION CRITERIA (INC EXC S) INCLUSION/EXCLUSION CRITERIA…
BNT162b2 BLA STN 125742/0 M 1.11.3 Response to FDA Information Requ est PFIZER CONFIDENTIAL 1BNT162b2 (COMIRNATY) BLA STN 125742/0 Response to CBER 22 July 2021 Information Request Regardin g Clinical ShellTables for Study C4591001 Follow -Up #4 ( Safety 508 Tables) August 2021 090177e197c190e3\Approved\Approved On: 08-Aug-2021 14:35 (GMT) FDA-CBER-2021-5683-1007503 BNT162b2 BLA STN 125742/0 M 1.11.3 Response to FDA Information Requ est PFIZER CONFIDENTIAL 2TABLE OF CONTENTS 1. INTRODUCTION…
Pfizer Global Regulatory Affairs Pfizer Inc . 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 09August 2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR …
Data Fitness Findings Report IND27034 BioNTech SE and Pfizer , April 2021 Findings Notes C4591001 EUA Amendment (12 -15 Years of Age) Title: A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID - 19 in Healthy Individuals. Document / Standard Version Notes annotated CRF Seems fine SDTM Implementation Guide SDTM -IG v3.2 SDTM Controlled Terminology 2020-03-27 SDTM define.xml V2.0 Seems…
Data Fitness Findings Report IND27034 BioNTech SE and Pfizer , November 2020 Findings Notes BNT162 -01 Title: A Multi- site, Phase I/II, 2 -Part, Dose -Escalation Trial Investigating the Safety and Immunogenicity of Four Prophylactic SARS -CoV-2 RNA Vaccines Against COVID -19 Using Different Dosing Regimens in Healthy Adults Document / Standard Version Notes annotated CRF Seems fine SDTM Implementation Guide SDTM -IG v3. 2 SDTM Controlled Terminology 2020-03-27 …
Page 1 of 389 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1095 Site Name: (1095) Tekton Research Subject No: 10951101 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:39 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Page 1 of 219 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1095 Site Name: (1095) Tekton Research Subject No: 10951080 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:39 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Page 1 of 460 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1095 Site Name: (1095) Tekton Research Subject No: 10951009 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:39 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…
Page 1 of 420 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1093 Site Name: (1093) Meridian Clinical Research Subject No: 10931141 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:31 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option…
Page 1 of 112 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1093 Site Name: (1093) Meridian Clinical Research Subject No: 10931128 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:31 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option…
Page 1 of 133 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1093 Site Name: (1093) Meridian Clinical Research Subject No: 10931067 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:31 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option…
Page 1 of 154 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1093 Site Name: (1093) Meridian Clinical Research Subject No: 10931058 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:31 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option…
Compound: PF -07302048; Protocol: C4591001 Page 1of 157 ========================================================================================================================== PFIZER CONFIDENTIAL SDTM Creation: . (.) Source Data: adsl Output File: ./nda2/C4591001_Narratives_Abbr/profile D ate o f Generation: 26MAR2021 (13:22)Table of Abbreviations Category Abbreviation Text Action -Subject N No action O Other P Drug withdrawn (study intervention discontinued) TC Concomitant…